Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

TM9538CP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

920dc32c-1a7f-4241-ae53-4f86a4717071

Public Version Date

December 31, 2018

Public Version Number

1

DI Record Publish Date

November 29, 2018

Package DI Number

M752TM9538CP5

Quantity per Package

40

Contains DI Package

M752TM9538CP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer box